Original Article

Effectiveness and tolerability of high-dose salmeterol in cystic fibrosis†

  1. Nancy L. Hordvik BS, RRT,
  2. Paul H. Sammut MD,
  3. C. Gerald Judy MD,
  4. John L. Colombo MD*

Article first published online: 30 AUG 2002

DOI: 10.1002/ppul.10162

Issue

Pediatric Pulmonology

Pediatric Pulmonology

Volume 34, Issue 4, pages 287–296, October 2002

Additional Information

How to Cite

Hordvik, N. L., Sammut, P. H., Judy, C. G. and Colombo, J. L. (2002), Effectiveness and tolerability of high-dose salmeterol in cystic fibrosis. Pediatric Pulmonology, 34: 287–296. doi: 10.1002/ppul.10162

Author Information

  1. Department of Pediatric Pulmonology, University of Nebraska Medical Center, Omaha, Nebraska

*University of Nebraska Medical Center, 985190 Nebraska Medical Center, Omaha, NE 68198-5190.

  1. †

    This study was presented at the Fourteenth Annual North American Cystic Fibrosis Conference in Baltimore, Maryland, November 9–12, 2000.

Publication History

  1. Issue published online: 30 AUG 2002
  2. Article first published online: 30 AUG 2002
  3. Manuscript Accepted: 17 JUN 2002
  4. Manuscript Received: 4 MAR 2002

Funded by

  • Glaxo Wellcome, Inc.

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Keywords:

  • cystic fibrosis;
  • albuterol;
  • salmeterol;
  • bronchodilators

Abstract

The efficacy and tolerability of high-dose salmeterol (100 mcg, BID) and albuterol (2.5 mg, BID) were compared with those of albuterol (2.5 mg, BID) in outpatients with cystic fibrosis in a randomized, double-blind, double-dummy, placebo-controlled, crossover study with both short- (4 weeks of each) and long-term (24 weeks of each) treatment periods. The primary outcome measure was the difference in mean change in forced expired volume in 1 sec (FEV1) from baseline to the end of each treatment, and secondary measures included changes in forced vital capacity (FVC), forced expiratory flow between 25–75% of FVC (FEF25–75), patient-rated weekly symptom scores, number of extra (rescue) albuterol treatments, and number of antibiotic treatments. Tolerability was evaluated by changes in vital signs and adverse events.

Thirty-six out of 44 patients enrolled finished the short-term treatment period, and 19 out of 23 who continued the study also finished the long-term treatment period. There was no significant difference in the mean % change in FEV1 from baseline to completion of 4 weeks with each drug in the short-term treatment period (0.1% vs. 0.06%, albuterol vs. salmeterol; respectively). In the long-term treatment period, there was a significant decrease from baseline in FEV1 with albuterol vs. salmeterol, as measured after both 12 and 24 weeks of each treatment (−6.2% vs. 1.8%, P = 0.013 after 12 weeks, and −6.5% vs. 1.7%, P = 0.002, after 24 weeks, respectively). In both treatment periods, salmeterol was well-tolerated. While there were more rescue treatments per patient per week with albuterol than with salmeterol treatment in both the short- and long-term periods (0.67 vs. 0.40 and 1.76 vs. 0.74, respectively), rescue treatments were needed significantly more often for only the long-term period with albuterol compared to salmeterol (P = 0.022). Also, there were more antibiotic interventions with albuterol than with salmeterol treatment in both the short- and long-term periods (25 vs. 10 and 56 vs. 42, respectively); however, antibiotics were needed significantly more often for only the short-term period (P = 0.011). In addition, there was a significantly higher symptom score with albuterol vs. salmeterol treatment during the second half of the long-term period (1.24 vs. 0.89, P = 0.001).

In conclusion, long-term high-dose salmeterol was equally safe and was associated with better pulmonary function, fewer interventions, and fewer respiratory symptoms compared to standard therapy with albuterol in a population of outpatients with mild to moderate CF. Pediatr Pulmonol. 2002; 34:287–296. © 2002 Wiley-Liss, Inc.

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